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| Name | Class |
|---|---|
| Kyungpook National University Chilgok Hospital | OTHER |
| Yeungnam University Hospital | OTHER |
| Ewha Womans University | OTHER |
| Baxter Healthcare Corporation |
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Theranova is a novel medium cut-off dialyzer and has better performance for removal of middle molecules compared to conventional hemodialysis. The study investigates the effect of Theranova dialzyer on preserving residual renal function in the incident hemodialysis pateitns compared to high-flux dialzyer. The primary endpoint is change of glomerular filtration rate, calculated using creatinine and urea clearance. The secondary endpoints are serial changes of glomerular filtration rate and daily urine volume, changes of serum middle molecule concentrations, hospitalization, mortality, and patient reported outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCO group | Experimental | Hemodialysis using Theranova 400 dialyzer |
|
| High-flux group | Active Comparator | Hemodialysis using high-flux dialyzer (Fx CorDiax 80; Fresenius Medical Care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theranova 400 dialyzer | Device | Hemodialysis using Theranova 400 dialyzer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of glomerular filtration rate | Glomerular filtration rate is calculated as the mean of creatinine and urea clearance adjusted for body surface area. The outcome refers to the mean difference of glomerular filtration rate between baseline and after 12 months. | Between baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of glomerular filtration rate | Calculated as the mean of creatinine and urea clearance adjusted for body surface area | 0, 3, 6, 9, 12 months |
| Change of daily urine volume | Total urine output for 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook national university chilgok hospital | Daegu | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27587605 | Background | Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310. | |
| 40036081 | Derived | Lim JH, Seo YJ, Jeon Y, Jeon YH, Jung HY, Choi JY, Park SH, Kim CD, Kang SH, Ryu JH, Kang DH, Cho JH, Kim YL. Expanded Hemodialysis with Theranova Dialyzer and Residual Kidney Function in Patients Starting Long-Term Hemodialysis: A Randomized Controlled Trial. J Am Soc Nephrol. 2025 Mar 4;36(8):1614-1625. doi: 10.1681/ASN.0000000655. |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| INDUSTRY |
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| High-flux dialyzer |
| Device |
Hemodialysis using high-flux dialyzer |
|
|
| 0, 3, 6, 9, 12 months |
| Change and reduction ratio of inflammatory marker levels | TNF-alpha, GDF-15, etc. | 0, 12 months |
| Change of hs-CRP | hs-CRP | 0, 12 months |
| Change of Beta 2-microglobulin | Beta 2-microglobulin | 0, 12 months |
| Change of kidney injury markers | NGAL, KIM-1, TIMP-2, IGFBP-7, etc | 0, 12 months |
| Change of cystatin-C | Cystatin-C | 0, 12 months |
| Change and reduction ratio of Kappa and lambda free light chains | Kappa and lambda free light chains | 0, 12 months |
| Hospitalization | Frequency, cause, etc. | Through 12-month study duration |
| Mortality | Deaths number and causes of death | Through 12-month study duration |
| Patient-reported outcome | Using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™; score ranges from 0 to 100 - higher scores represent better quality of life) | 0, 12 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |